CTCA doses first patient in groundbreaking immunotherapy clinical trial

Bioscience | 5 Dec, 2019 |

Clinical investigators at Cancer Treatment Centers of America (CTCA) in Phoenix have dosed the first patient in the first-in-human study of NKTR-255, a first-in-class immunotherapy developed by Nektar Therapeutics. This Phase 1 clinical study will evaluate the safety and tolerability of NKTR-255 as a monotherapy for patients with relapsed or refractory non-Hodgkin lymphoma (NHL) or multiple myeloma. The study will also combine NKTR-255 with multiple targeted antibodies that function through an antibody-dependent cell-mediated cytotoxicity (ADCC) mechanism, to evaluate the safety and tolerability in adults with relapsed or refractory multiple myeloma.

“Dosing the first patient in this clinical trial is an example of CTCA’s commitment to streamlining the activation of trials so that promising therapies may be more quickly identified, developed and approved for patients who are in need of new treatment options,” said Maurie Markman, MD, President of CTCA Medicine & Science. “While the era of immunotherapy has led to great progress, more research is needed and we must continue to explore additional pathways and approaches, as many patients are not eligible for currently available immuno-oncology treatments.”

Of the approximately 74,200 people diagnosed with NHL each year in the U.S., it is estimated that 19,970 patients will die of their disease.1 While relatively uncommon, approximately 32,110 people will be diagnosed with multiple myeloma in the U.S. each year, and about 12,960 will die of their disease.2

“For decades, multiple myeloma and non-Hodgkin lymphoma were blood cancers with limited therapeutic options using a patient’s own immune system,” said Alan Tan, MD, Clinical Research Medical Director, Hematologist and Medical Oncologist at CTCA Phoenix. “We are excited to be part of this Phase 1 clinical trial which may help to usher in a whole new class of drugs for these patients.”

For more information about open clinical trials at CTCA, visit cancercenter.com/clinical-trials.

About the NKTR-255 Phase 1 Study

The NKTR-255 Phase 1 study is an open-label, dose escalation and dose expansion study in patients with select hematological malignancies (relapsed or refractory NHL or MM). The dose escalation phase of the study will evaluate the safety and tolerability of NKTR-255 as monotherapy in approximately 40 patients in order to establish a recommended Phase 2 dose (RP2D) for NKTR-255. The dose expansion phase of the study will enroll in two separate cohorts: the first cohort will enroll patients with MM or NHL (relapsed salvage) to evaluate the safety and tolerability of the NKTR-255 RP2D as a monotherapy and the second cohort will enroll patients with MM or NHL (relapsed/refractory salvage) to evaluate the  safety and tolerability of NKTR-255 RP2D in combination with targeted antibodies, including anti-CD38 monoclonal antibody, daratumumab. The study will also evaluate pharmacokinetic and pharmacodynamic effects, anti-tumor activity and biomarker assessments. For more information, visit clinicaltrials.gov and search locator NCT04136756.

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